Accreditation group releases Md. General inspection report

State wants to know how troubled lab got top rating

April 29, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

Under pressure from Maryland's top health official, a national accreditation organization has reversed itself and turned over to the state its most recent inspection report on the troubled laboratory at Maryland General Hospital.

State Health Secretary Nelson J. Sabatini said the inspection report arrived yesterday by Federal Express from the Illinois-based College of American Pathologists. The organization had rebuffed prior requests for the report, contending that it did not have "a relationship with the state of Maryland."

Sabatini, who had demanded a response from the organization by the end of this week, said the state Office of Health Care Quality will examine the inspection report as part of a continuing review of Maryland General's operations.

"We want to look at that report and try to reconcile how the laboratory got accredited at the same time it was experiencing so many problems," the health secretary said in an interview shortly after the report arrived.

Sabatini had threatened to revoke the approval for about 120 laboratories across the state that were certified by the Illinois nonprofit unless the Maryland General report was released. The inspection report was issued in July and was based on an inspection in April 2003. The laboratory was given the top designation: "Accredited with Distinction."

Subsequent inspections by state officials, prompted by a whistleblower, showed that the laboratory was in the midst of serious problems at the very time the accreditation inspection was conducted.

Errors ignored

After a series of its own inspections early this year, state officials concluded that Maryland General issued about 460 HIV and hepatitis test results over a 14-month period, ignoring instrument readings showing that the test results might be in error. In fact, lab workers say they were ordered to edit out the readings warning of possible errors.

As a result of the state findings, the hospital, an affiliate of the University of Maryland Health System, has agreed to provide new tests to more than 2,000 patients and implemented a detailed corrective action plan. Three top officials at the hospital, including its president, have resigned.

Sabatini said he was pleased the report had been released, but the question of how the laboratory got the agency's top accreditation rating remains unanswered.

`Mutual concerns'

In a written statement released late yesterday, the College of American Pathologists acknowledged that it had released the report to Sabatini and said it would honor future requests for similar information.

"The college would of course respond to similar requests from the state of Maryland. In fact, we are hoping to meet with representatives of the Maryland State Dept. of Health and Mental Hygiene to discuss our mutual concerns for the quality and patient safety of medical testing in Maryland," the statement reads.

This month, a spokesman for the organization said the problems ultimately found by the state would not be immediately apparent in a routine inspection.

"The nature of the problem ... is such that a routine accreditation inspection would not have readily identified the problem without a prior complaint having been filed," said spokesman Anthony Phipps, adding that very specific information was later provided to the state.

A worker's complaint

In fact, it was a complaint from Kristin Turner, a former Maryland General laboratory technician, that triggered the state inspections.

Just weeks before the accreditation agency conducted its favorable inspection, Turner says she was infected with HIV and hepatitis when a laboratory testing device malfunctioned. Turner, 32, who has sued the hospital and the equipment manufacturer, says she was splattered with infected blood March 12 last year.

The pathologists group, under an agreement sanctioned by the federal government, inspects and certifies laboratories across the country. Until the current dispute erupted, Maryland officials had routinely accepted the organization's accreditations.